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Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT00947115
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : May 2, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Procedure: Blood sampling
Procedure: Cervico-vaginal secretion (CVS) samples
Enrollment 525
Recruitment Details  
Pre-assignment Details Out of the 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524. However, not all subjects came to all study visits, hence the actual starting numbers varied depending on the rate of return.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Period Title: Year 5 (Month 60)
Started 153 184 170
Completed 153 184 170
Not Completed 0 0 0
Period Title: Year 6 (Month 72)
Started 147 177 164
Completed 147 177 164
Not Completed 0 0 0
Period Title: Year 7 (Month 84)
Started 149 165 160
Completed 149 165 160
Not Completed 0 0 0
Period Title: Year 8 (Month 96)
Started 137 152 141
Completed 137 152 141
Not Completed 0 0 0
Period Title: Year 9 (Month 108)
Started 146 180 157
Completed 146 180 157
Not Completed 0 0 0
Period Title: Year 10 (Month 120)
Started 142 172 156
Completed 142 172 156
Not Completed 0 0 0
Period Title: Year 0 (Month 0) - Year 10 (Month 120)
Started 159 194 171
Completed 142 172 156
Not Completed 17 22 15
Reason Not Completed
Missed reporting interval             3             4             2
Physician Decision             0             2             0
Death             0             1             1
Migrated from study area             2             0             0
Withdrawal by Subject             1             3             4
Lost to Follow-up             11             12             8
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group Total
Hide Arm/Group Description Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Total of all reporting groups
Overall Number of Baseline Participants 159 194 171 524
Hide Baseline Analysis Population Description
Some subjects who came for the Year 5 timepoint did not return for the Year 6, 7, 8 or 9 timepoints, hence the numbers of subjects starting each year (based on the actual rate of return for visits) do not correspond to the ones of the previous years.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
25.7  (2.82) 41.0  (6.02) 54.4  (3.15) 40.9  (12.22)
[1]
Measure Description: Data for Year 5
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
26.6  (2.85) 41.8  (6.05) 55.4  (3.20) 41.8  (12.28)
[1]
Measure Description: Data for year 6
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
27.5  (2.78) 42.9  (5.96) 56.4  (3.23) 42.6  (12.42)
[1]
Measure Description: Data for Year 7
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
28.3  (2.8) 44.0  (6.0) 57.6  (2.9) 35.6  (12.57)
[1]
Measure Description: Data for Year 8
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
29.5  (2.8) 45.2  (6.0) 58.6  (2.9) 44.8  (12.32)
[1]
Measure Description: Data for Year 9
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
30.6  (2.8) 46.1  (6.0) 59.6  (2.8) 45.9  (12.3)
[1]
Measure Description: Data for Year 10
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 194 participants 171 participants 524 participants
30.6  (2.8) 46.1  (6.0) 59.6  (2.8) 45.8  (12.3)
[1]
Measure Description: Data for Year 0 - Year 10
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female 153 184 170 507
Male 0 0 0 0
[1]
Measure Description: Data for Year 5
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female 147 177 164 488
Male 0 0 0 0
[1]
Measure Description: Data for Year 6
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female 149 165 160 474
Male 0 0 0 0
[1]
Measure Description: Data for Year 7
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female 137 152 141 430
Male 0 0 0 0
[1]
Measure Description: Data for Year 8
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female 146 180 157 483
Male 0 0 0 0
[1]
Measure Description: Data for Year 9
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female 142 172 156 470
Male 0 0 0 0
[1]
Measure Description: Data for Year 10
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 194 participants 171 participants 524 participants
Female
159
 100.0%
194
 100.0%
171
 100.0%
524
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Data for Year 0 - Year 10
1.Primary Outcome
Title Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum
Hide Description Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time Frame At Year 5, 6 and 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 146 171 166
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 [Year 5] (N=146; 169; 164)
1473.4
(1246.6 to 1741.5)
620.0
(512.8 to 749.6)
399.5
(330.8 to 482.4)
Anti-HPV-18 [Year 5] (N= 145; 168; 166)
439.7
(370.4 to 522.1)
183.6
(155.2 to 217.1)
119.3
(98.8 to 144.0)
Anti-HPV-16 [Year 6] (N=145; 171; 159)
1358.0
(1155.4 to 1596.0)
591.9
(497.8 to 703.9)
389.8
(320.9 to 473.5)
Anti-HPV-18 [Year 6] (N= 144; 171; 161)
448.2
(378.1 to 531.2)
182.3
(153.0 to 217.3)
112.7
(92.3 to 137.6)
Anti-HPV-16 [Year 7] (N=142; 160; 153)
1011.4
(854.1 to 1197.7)
435.1
(355.9 to 532.0)
288.5
(235.0 to 354.2)
Anti-HPV-18 [Year 7] (N= 141; 159; 155)
317.0
(265.9 to 377.8)
134.5
(112.1 to 161.4)
92.6
(75.3 to 114.0)
2.Primary Outcome
Title Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum
Hide Description Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.
Time Frame At Years 8, 9 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 144 172 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
anti-HPV-16 [Year 8] (N= 132; 143; 135)
1114.4
(936.6 to 1325.8)
435.4
(358.1 to 529.3)
279.0
(224.7 to 346.3)
anti-HPV-16 [Year 9] (N= 144; 172; 151)
976.1
(832.0 to 1145.3)
402.5
(340.2 to 476.1)
265.5
(216.4 to 325.8)
anti-HPV-16 [Year 10] (N= 140; 162; 147)
954.9
(804.2 to 1133.9)
369.4
(306.3 to 445.6)
228.6
(185.8 to 281.4)
anti-HPV-18 [Year 8] (N= 131; 143; 137)
387.9
(323.7 to 464.8)
146.5
(120.0 to 178.9)
95.7
(77.0 to 118.9)
anti-HPV-18 [Year 9] (N= 143; 172; 153)
330.0
(277.1 to 392.9)
136.1
(114.1 to 162.4)
87.2
(71.0 to 107.0)
anti-HPV-18 [Year 10] (N= 139; 162; 149)
327.1
(271.8 to 393.7)
128.2
(105.9 to 155.1)
81.6
(66.2 to 100.5)
3.Primary Outcome
Title Number of Seroconverted Subjects.
Hide Description Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.
Time Frame At Year 5, 6 and 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 134 146 146
Measure Type: Number
Unit of Measure: Subjects
anti-HPV-16 [Year 5] (N= 128; 127; 118) 128 127 118
anti-HPV-18 [Year 5] (N= 134; 144; 146) 134 144 143
anti-HPV-16 [Year 6] (N= 128; 130; 116) 128 130 116
anti-HPV-18 [Year 6] (N= 133; 146; 142) 133 146 138
anti-HPV-16 [Year 7] (N= 125; 119; 111) 125 119 111
anti-HPV-18 [Year 7] (N= 130; 136; 137) 130 135 131
4.Primary Outcome
Title Number of Seroconverted Subjects.
Hide Description Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.
Time Frame At Years 8, 9 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 132 148 132
Measure Type: Number
Unit of Measure: Subjects
anti-HPV-16 [Year 8] (N= 116; 106; 99) 116 106 95
anti-HPV-16 [Year 9] (N= 127; 132; 110) 127 132 106
anti-HPV-16 [Year 10] (N= 123; 121; 107) 123 120 103
anti-HPV-18 [Year 8] (N= 120; 123; 120) 120 118 104
anti-HPV-18 [Year 9] (N= 132; 148; 132) 132 141 113
anti-HPV-18 [Year 10] (N= 127; 142; 130) 126 133 109
5.Secondary Outcome
Title Total Immunoglobulin G (IgG) Antibody Titers in Serum
Hide Description IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
Time Frame At Year 5, 6 and 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 68 65 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Total IgG serum antibodies [Year 5] (N=68;65;60)
19481.8
(18076.2 to 20996.8)
18388.2
(16844.6 to 20073.3)
17657.2
(16046.7 to 19429.4)
Total IgG serum antibodies [Year 6] (N=41;38;33)
13376.5
(12498.7 to 14315.9)
12262.7
(11304.8 to 13301.8)
12040.2
(10854.4 to 13355.7)
Total IgG serum antibodies [Year 7] (N=59;63;57)
13957.2
(13116.6 to 14851.7)
13179.4
(12287.7 to 14135.7)
12992.9
(12096.6 to 13955.4)
6.Secondary Outcome
Title Total Immunoglobulin G (IgG) Antibody Titers in Serum
Hide Description IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
Time Frame At Years 8, 9 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 61 62 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Total IgG serum antibodies [Year 8] (N=57;58;55)
11059.5
(10547.8 to 11596.0)
10656.3
(10057.6 to 11290.6)
10605.7
(10061.4 to 11179.5)
Total IgG serum antibodies [Year 9] (N=60;56;54)
11212.2
(10661.3 to 11791.6)
10693.8
(10067.0 to 11359.7)
10427.8
(9871.3 to 11015.6)
Total IgG serum antibodies [Year 10] (N=61;62;51)
11071.3
(10546.9 to 11621.8)
10650.8
(10079.2 to 11254.7)
10535.0
(9979.4 to 11121.5)
7.Secondary Outcome
Title Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)
Hide Description Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).
Time Frame At Year 5 and Year 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 39 39 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 [Year 5] (N=39;39;28)
90.2
(61.9 to 131.3)
47.2
(32.2 to 69.2)
56.8
(28.7 to 112.4)
Anti-HPV-18 [Year 5] (N=39;39;28)
30.9
(20.9 to 45.6)
24.6
(14.8 to 41.0)
33.3
(15.8 to 70.0)
Anti-HPV-16 [Year 6] (N=29;29;26)
80.3
(46.8 to 137.8)
43.8
(26.0 to 73.9)
37.1
(20.8 to 66.0)
Anti-HPV-18 [Year 6] (N=29;29;26)
22.9
(13.8 to 37.9)
19.9
(11.4 to 34.9)
19.2
(11.7 to 31.8)
8.Secondary Outcome
Title Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)
Hide Description Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).
Time Frame At Years 7, 8, 9, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 41 40 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 [Year 7] (N=31;30;30)
63.0
(38.6 to 102.9)
33.3
(21.6 to 51.2)
42.3
(25.0 to 71.5)
Anti-HPV-18 [Year 7] (N=31;31;30)
33.5
(19.8 to 56.6)
17.5
(10.2 to 30.1)
49.0
(22.4 to 107.3)
Anti-HPV-16 [Year 8] (N=31;34;32)
45.6
(29.6 to 70.1)
43.9
(24.8 to 77.7)
54.6
(34.3 to 86.8)
Anti-HPV-18 [Year 8] (N=31;34;32)
17.8
(11.2 to 28.4)
26.2
(14.7 to 46.8)
31.9
(14.7 to 69.2)
Anti-HPV-16 [Year 9] (N=32;35;27)
67.7
(45.4 to 101.0)
42.6
(23.6 to 76.8)
62.6
(36.7 to 106.5)
Anti-HPV-18 [Year 9] (N=32;35;27)
28.1
(18.5 to 42.8)
23.9
(15.8 to 36.1)
50.4
(25.1 to 101.3)
Anti-HPV-16 [Year 10] (N=41;40;26)
43.4
(28.1 to 67.1)
34.3
(24.1 to 48.7)
56.0
(31.5 to 99.7)
Anti-HPV-18 [Year 10] (N=41;40;26)
29.4
(17.6 to 49.4)
22.7
(13.8 to 37.3)
45.1
(22.9 to 88.6)
9.Secondary Outcome
Title Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS
Hide Description Titers were given as GMTs expressed in microgram per milliliter (µg/mL).
Time Frame At Year 5 and Year 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 39 39 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
IgG secretion antibodies [Year 5] (N=39;39;28)
577.8
(411.3 to 811.6)
550.5
(373.7 to 811.0)
990.6
(540.2 to 1816.4)
IgG secretion antibodies [Year 6] (N=29;29;26)
546.5
(352.2 to 848.2)
499.8
(327.7 to 762.2)
1012.9
(696.7 to 1472.6)
10.Secondary Outcome
Title Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS
Hide Description Titers were given as GMTs expressed in microgram per milliliter (µg/mL)
Time Frame At Years 7, 8, 9, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom their CVS sample contained less than 200 erythrocytes per microliter.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 39 37 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
IgG secretion antibodies [Year 7] (N=31;31;30)
517.5
(348.1 to 769.4)
372.2
(236.7 to 585.4)
1263.2
(793.8 to 2010.2)
IgG secretion antibodies [Year 8] (N=31;34;32)
304.8
(211.1 to 440.1)
457.2
(308.2 to 678.2)
928.2
(578.0 to 1490.6)
IgG secretion antibodies [Year 9] (N=32;33;26)
435.1
(293.2 to 645.8)
460.4
(301.7 to 702.4)
925.8
(586.3 to 1461.8)
IgG secretion antibodies [Year 10] (N=39;37;24)
315.3
(237.9 to 417.8)
373.5
(259.9 to 536.8)
622.9
(405.2 to 957.5)
11.Secondary Outcome
Title Total Immunoglobulin G (IgG) Antibody Titers in Serum
Hide Description IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
Time Frame At Year 5, 6 and 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort at Years 5, 6 and 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 69 68 61
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Total IgG serum antibodies [Year 5] (N=69;68;61)
19453.0
(18068.5 to 20943.6)
18092.4
(16566.3 to 19759.1)
17885.0
(16224.1 to 19715.9)
Total IgG serum antibodies [Year 6] (N=42;39;33)
13318.5
(12458.3 to 14238.1)
12173.1
(11231.2 to 13193.9)
12040.2
(10854.4 to 13355.7)
Total IgG serum antibodies [Year 7] (N=59;66;58)
13957.2
(13116.6 to 14851.7)
13059.5
(12205.2 to 13973.6)
13052.9
(12160.9 to 14010.5)
12.Secondary Outcome
Title Total Immunoglobulin G (IgG) Antibody Titers in Serum
Hide Description IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
Time Frame At Years 8, 9 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 62 66 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Total IgG serum antibodies [Year 8] (N=58;61;57)
11084.4
(10578.2 to 11614.8)
10602.4
(10010.8 to 11229.1)
10725.5
(10151.1 to 11332.4)
Total IgG serum antibodies [Year 9] (N=60;56;54)
11212.2
(10661.3 to 11791.6)
10693.8
(10067.0 to 11359.7)
10427.8
(9871.3 to 11015.6)
Total IgG serum antibodies [Year 10] (N=62;66;55)
11043.6
(10526.3 to 11586.4)
10511.3
(9938.6 to 11117.0)
10484.8
(9947.5 to 11051.1)
13.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort at Year 5, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 5.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 153 184 170
Measure Type: Number
Unit of Measure: Subjects
0 0 0
14.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort at Year 6, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 6.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 147 177 164
Measure Type: Number
Unit of Measure: Subjects
0 0 0
15.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 72 (Year 6) visit to Month 84 (Year 7) visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort at Year 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 7.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 149 165 160
Measure Type: Number
Unit of Measure: Subjects
0 0 0
16.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 84 (Year 7) to the Month 96 (Year 8) visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort at Year 8, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 8.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 137 147 146
Measure Type: Number
Unit of Measure: Subjects
0 0 0
17.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 96 (Year 8) to the Month 108 (Year 9) visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort at Year 9, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 9.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 146 175 162
Measure Type: Number
Unit of Measure: Subjects
0 1 0
18.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 108 (Year 9) to the Month 120 (Year 10) visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort at Year 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 10.
Arm/Group Title Cervarix 15-45 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 146 175 162
Measure Type: Number
Unit of Measure: Subjects
0 1 1
19.Secondary Outcome
Title Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Year 0 up to Year 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available throughout the study.
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description:
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Overall Number of Participants Analyzed 159 194 171
Measure Type: Number
Unit of Measure: Subjects
0 2 1
Time Frame SAEs: throughout the entire study from Day 0 up to the Year 10 visit.
Adverse Event Reporting Description Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in study NCT00196937, excluding those who were not selected or not consented for this NCT00947115 study.
 
Arm/Group Title Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Hide Arm/Group Description Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937) Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
All-Cause Mortality
Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/159 (0.00%)   2/194 (1.03%)   1/171 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Chronic lymphocytic leukaemia *  0/159 (0.00%)  1/194 (0.52%)  0/171 (0.00%) 
Lung neoplasm malignant *  0/159 (0.00%)  0/194 (0.00%)  1/171 (0.58%) 
Reproductive system and breast disorders       
Cervical displasia *  0/159 (0.00%)  1/194 (0.52%)  0/171 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix 15-25 Years Group Cervarix 26-45 Years Group Cervarix 46-55 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00947115     History of Changes
Other Study ID Numbers: 112772
First Submitted: July 16, 2009
First Posted: July 27, 2009
Results First Submitted: February 10, 2011
Results First Posted: May 2, 2011
Last Update Posted: February 23, 2017